Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim

Eastern Cooperative Oncology Group48 enrolled

Overview

RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment. PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.

OBJECTIVES: Primary * To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome. Secondary * To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical outcome. OUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF neutralizing antibody assay.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma (Skin)

Interventions

flow cytometryOTHER

immunologic techniqueOTHER

laboratory biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosed with melanoma * Stage IV disease * HLA-A2\^+ and A2\^+ * Received sargramostim on clinical trial ECOG-4697 * Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Outcomes

Primary Outcomes

Overall and disease-free survival

Time frame: 1 year

Data from ClinicalTrials.gov

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